$NVLX According to the American cancer Society, in the US alone, approximately 45,000 new cases of pancreatic cancer are expected to be diagnosed this year and about 38,000 people are predicted to die from the disease; it is the leading cause of cancer deaths in the US and worldwide. Often pancreatic cancer is not diagnosed until it has reached an advanced stage. By this time, the cancer cannot be removed surgically, is often resistant to radiation therapy or chemotherapy, and has spread (metastasized) to other organs in the body. Because of this, the average survival of patients with advanced, inoperable pancreatic cancer is given in terms of weeks or months, not years.Nuvilex’s pancreatic cancer treatment consists of the use of a proprietary cellulose-based live-cell encapsulation technology together with the long-known and widely used anticancer drug ifosfamide.In a Phase I/II open-label, prospective, single-arm clinical trial, the live-cell encapsulation/ifosfamide combination was used to treat patients with advanced, inoperable pancreatic cancer. Fifty-one patients were originally “screened” for the trial; of these, 17 were enrolled in the study. Other patients were excluded from enrollment for therapy because of previous chemotherapy, previous pancreatic surgery, poor overall health, unwillingness to participate, or death prior to the start of the trial. Of the 17 patients initially enrolled in the study, 14 were ultimately treated. Results obtained in the clinical trial were compared with historical data for gemcitabine and included: median survival time of 44 weeks (after diagnosis) with the cell encapsulation/ifosfamide treatment as compared to 28 weeks with gemcitabine; doubling of the one-year survival rate – 36% with our treatment vs. 18% with gemcitabine; tumor volume was reduced 25-50% in 4 of the 14 treated patients and remained stable in the remaining patients; no serious drug-related side effects with the encapsulated cell/ifosfamide treatment whereas serious and very serious side effects were reported with gemcitabine; the lack of serious side effects using our treatment is probably related to the use of “lower than normal” doses of ifosfamide; limited side effects and reduced cancer pain intensity led to a generally increased ‘quality of life” for the majority of patients. In a “worst case” scenario, some clinical benefit was seen in 50% of patients and in a “best case” scenario, this number increased to 71%; none of the patients who experienced a clinical benefit required and increase in their pain medication.
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